UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051402 |
|---|---|
| Receipt number | R000058639 |
| Scientific Title | Foot Care to Prevent Falls for The Elderly who Need Nursing Care - Effects of Hot Towel on Flexibility and Standing Balance of Ankle Joint- |
| Date of disclosure of the study information | 2023/06/21 |
| Last modified on | 2023/12/15 14:19:16 |
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Basic information
Public title
Foot Care for Preventing Falls in Elderly People - Application of Hot Towels on Ankle Joint Flexibility and Standing Balance-
Acronym
Foot Care for Support Fall Prevention in the Elderly- Effects of Hot Towel on Ankle Joint Flexibility and Standing Balance-
Scientific Title
Foot Care to Prevent Falls for The Elderly who Need Nursing Care - Effects of Hot Towel on Flexibility and Standing Balance of Ankle Joint-
Scientific Title:Acronym
Foot Care for Preventing fall in Elderly People
Region
| Japan |
Condition
Condition
Healthy eldery people
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of hot towels on Ankle joint flexibility and balance in the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dorsal fiexion angle of the ankle joint
Key secondary outcomes
Deep temperature
Time to open eyes and stand on one leg
Toe grip
Center of gravity sway measurement
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1.observation
2.hot moist compresses
3.washout period;1 week or more
4.rest lying down
5.observation
Interventions/Control_2
1.observation
2.resting and lying down
3.washout period;1 week or more
4.hot moist compresses
5.observation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy eldery people who agreed to participate this study
Key exclusion criteria
Persons suffering from neurological, bone, or joint diseases that significantly affect standing
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Harumi |
| Middle name | |
| Last name | Kohri |
Organization
Miyazaki Prefectural Nursing University
Division name
School of Nursing Department of Nursing
Zip code
880-0929
Address
3-5-1, Manabino,Miyazaki-city, Miyazaki
TEL
0985597741
kohri@mpu.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Tanaka |
Organization
Miyazaki Prefectural Nursing University
Division name
School of Nursing Department of Nursing
Zip code
8800929
Address
3-5-1, Manabino,Miyazaki-city,Miyazaki
TEL
0958597700
Homepage URL
michiko-ta@mpu.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Miyazaki Prefectural Nursing University
Address
3-5-1, Manabino,Miyazaki-city,Miyazaki
Tel
0958-59-7700
yuasa3@mpu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 13 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 13 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058639
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
